Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations. (IDENTIFY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01525199
First received: January 31, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.


Condition
Stage IIIB/IV
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 12 months after the diagnosis of advanced disease ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 12 months after the diagnosis of advanced disease ] [ Designated as safety issue: No ]
  • Number of hospitalizations [ Time Frame: 12 months after the diagnosis of advanced disease ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Control

Detailed Description:

Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from specialized sites; all the participating investigators will be oncologists.

Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
  • Patients under 1st line treatment against lung adenocarcinoma.

Exclusion Criteria:

  • Patients not having the information required by the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525199

Locations
Argentina
Research Site
Bahia Blanca, Buenos Aires, Argentina
Research Site
Bolivar, Buenos Aires, Argentina
Research Site
Ciudad de Buenos Aires, Buenos Aires, Argentina
Research Site
Junin, Buenos Aires, Argentina
Research Site
La Plata, Buenos Aires, Argentina
Research Site
Lanus, Buenos Aires, Argentina
Research Site
Lomas de Zamora, Buenos Aires, Argentina
Research Site
Mar del Plata, Buenos Aires, Argentina
Research Site
Santa Rosa, La Pampa, Argentina
Research Site
Gral. Roca, Rio Negro, Argentina
Research Site
Rosario, Santa Fe, Argentina
Research Site
Cordoba, Argentina
Research Site
La Rioja, Argentina
Research Site
Mendoza, Argentina
Research Site
San Luis, Argentina
Research Site
Santa Fe, Argentina
Research Site
Tucuman, Argentina
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01525199     History of Changes
Other Study ID Numbers: NIS-OAR-XXX-2011/1
Study First Received: January 31, 2012
Last Updated: April 11, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by AstraZeneca:
Non-Small Cell Lung Cancer,
Epidermal Growth Factor Receptor mutation,
Lung cancer,
Lung adenocarcinoma

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014